MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, KEELED BETA, MEDIUM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	314-01-13
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 0 year(s) and 7 month(s) post implantation of left revised tsa (revision captured on (b)(4), the patient presented with aseptic glenoid loosening.Glenoid loosening confirmed by ct-scan.This outcome of the event was resolved by standard total revision of the left shoulder.The clinical report indicates that the event is unlikely related to the device(s) and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-01-11, equinoxe, humeral stem primary, press fit 11mm.310-01-47, equinoxe, humeral head short, 47mm (beta).300-10-45, equinoxe replicator plate 4.5mm o/s.
Additional Manufacturer Narrative
(h3): the revision reported was likely the result of an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, the reported glenoid loosening could not be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, the reported glenoid loosening could not be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE GLENOID, KEELED BETA, MEDIUM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19506871
• Report Number: 1038671-2024-01874
• Device Sequence Number: 3418422
• Product Code: HSD
• UDI-Device Identifier: 10885862084446
• UDI-Public: 10885862084446
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 314-01-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 09/26/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 10/01/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male